Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Treating Patients With Stage III or Stage IV Follicular Lymphoma or Marginal Zone Lymphoma

This study has been terminated.
(Funding)
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00772668
First received: October 12, 2008
Last updated: August 13, 2013
Last verified: August 2013

October 12, 2008
August 13, 2013
September 2008
February 2011   (final data collection date for primary outcome measure)
Overall Response Rate, According to the International Workshop Criteria (IWC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Overall response rate, according to the International Workshop Criteria (IWC) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00772668 on ClinicalTrials.gov Archive Site
  • Progression-free Survival as Assessed by RECIST Criteria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety and Tolerance to Rituximab, Cyclophosphamide, Bortezomib, and Prednisone [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Progression-free survival as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety and tolerance to rituximab, cyclophosphamide, bortezomib and prednisone [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Treating Patients With Stage III or Stage IV Follicular Lymphoma or Marginal Zone Lymphoma
Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.

OBJECTIVES:

Primary

  • To determine the overall response rate, in terms of complete response (CR), unconfirmed CR, and partial response, in patients with follicular lymphoma or marginal zone lymphoma treated with rituximab, cyclophosphamide, bortezomib, and prednisone (R-CVelP) as first line of treatment.

Secondary

  • To determine progression-free survival of patients treated with this regimen.
  • To determine overall survival of patients treated with this regimen.
  • To determine the safety and tolerance to R-CVelP in these patients.

OUTLINE:

  • Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
  • Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Drug: Rituximab
    375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles
    Other Name: Rituxan
  • Drug: Bortezomib
    1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles
    Other Name: Velcade
  • Drug: Cyclophosphamide
    750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles
    Other Name: Cytoxan
  • Drug: Prednisone
    100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Experimental: RCVELP
Interventions:
  • Drug: Rituximab
  • Drug: Bortezomib
  • Drug: Cyclophosphamide
  • Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
February 2011
February 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed grade 1 or 2 follicular lymphoma (FL) or marginal zone lymphoma (MZL)

    • Stage III or IV disease
  • Measurable or evaluable disease
  • Previously untreated disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 1-3
  • ANC > 1,000/mm³
  • Platelet count > 100,000/mm³ (unless due to lymphoma)
  • Bilirubin < 2.0 mg/dL
  • Creatinine < 2 mg/dL (unless due to lymphoma)
  • AST, ALT, and alkaline phosphatase < 3 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No myocardial infarction within the past 6 months
  • No NYHA class III-IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No ECG evidence of acute ischemia or active conductive system abnormalities
  • No hypersensitivity to boron or mannitol
  • No serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • No history of HIV infection
  • No concurrent or previous malignancy with poor prognosis (< 90% probability of survival at 5 years) or actively treated for a second malignancy
  • No peripheral neuropathy ≥ grade 2 within the past 14 days

PRIOR CONCURRENT THERAPY:

  • No prior therapy for this disease including chemotherapy, single-agent rituximab, or radiotherapy
  • No other concurrent anticancer therapy including chemotherapy, radiation, hormonal treatment, or immunotherapy
  • At least 14 days since prior and no other concurrent investigational drugs
  • No concurrent participation in another clinical study
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00772668
UMIAMI-20070963, SCCC-2006120
Yes
University of Miami Sylvester Comprehensive Cancer Center
University of Miami Sylvester Comprehensive Cancer Center
Not Provided
Study Chair: Denise Pereira, MD University of Miami Sylvester Comprehensive Cancer Center
University of Miami Sylvester Comprehensive Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP